DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
Claims 1-20 are pending and under consideration for patentability.
Information Disclosure Statement
The Information Disclosure Statements submitted on 01 December 2023, 19 January 2024, and 24 December 2024 have been acknowledged and considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 7, 10-13, 15, 16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Mansi et al. (US 2016/0196384 A1).
Regarding claims 1, 10, and 19, Mansi describes a ventricular or pulmonary artery pressure waveform estimation device ([0043], [0052]) comprising a calculation unit configured to estimate a plurality of coefficients of a model equation ([0104], [0109]), the model equation configured to indicate a left ventricular pressure waveform or a right ventricular pressure waveform ([0025], [0039], figures 3 and 4) by using values of one or more parameters related to a heartbeat or an arterial pressure ([0039]) to estimate at least a part of the left ventricular pressure waveform or the right ventricular pressure waveform ([0025]).
Regarding claims 2 and 11, Mansi describes wherein the calculation unit is configured to estimate each coefficient of the plurality of coefficients of the model equation by using the one or more parameters as explanatory variables of a machine learning model ([0104], [0106], [0109]).
Regarding claims 3 and 12, Mansi describes wherein the machine learning model is constructed by acquiring a measured waveform of at least a part of the left ventricular or pulmonary artery pressure waveform or the right ventricular pressure waveform ([0030]), calculating values of the plurality of coefficients by fitting the model equation to the measured waveform ([0067]), generating a data set for machine learning in which the one or more parameters in the acquisition of the measured waveform are used as explanatory variables ([0039], the parameters are of input variables used to model) and the plurality of coefficients are used as objective variables, respectively ([0104]), and executing machine learning using the data set for machine learning ([0102] - [0103]).
Regarding claims 4 and 13, Mansi describes wherein the one or more parameters include one or more parameters related to the heartbeat and one or more parameters related to the arterial pressure ([0039]).
Regarding claims 6 and 15, Mansi describes wherein the calculation unit is configured to calculate a value of left ventricular end-diastolic pressure based on at least a part of the estimated left ventricular pressure waveform ([0025], [0093] - [0094], the model generates and computes metrics based on left or right ventricular pressure-volume loops; the Examiner respectfully submits that it is well established in the field that the end-diastolic pressure is determined from the pressure-volume loop as the pressure corresponding to the end of the diastolic filling phase, as highlighted by the Examiner on Mansi’s figure 8).
Regarding claims 7 and 16, Mansi describes wherein the calculation unit is configured to calculate an index of contractility of a left ventricle based on a slope of the estimated left ventricular pressure waveform ([0025], [0093] - [0094], figure 8; it is well-established in the field that the slope of the end-systolic pressure-volume relationship is a measure of cardiac contractility).
Regarding claim 20, Mansi describes estimating each coefficient of the plurality of coefficients of the model equation by using the one or more parameters as explanatory variables of a machine learning model ([0104], [0106], [0109]), wherein the machine learning model is constructed by acquiring a measured waveform of at least a part of the left ventricular or the right ventricular pressure waveform ([0030]), calculating values of the plurality of coefficients by fitting the model equation to the measured waveform ([0067]), generating a data set for machine learning in which the one or more parameters in the acquisition of the measured waveform are used as explanatory variables ([0039], the parameters are of input variables used to model) and the plurality of coefficients are used as objective variables, respectively ([0104]), and executing machine learning using the data set for machine learning ([0102] - [0103]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mansi in view of Selker et al. (US 2003/0032871 A1) and Ferber et al. (US 2017/0156676 A1).
Regarding claims 5 and 14, Mansi describes the ventricular waveform estimation device according to claim 1 and the pulmonary artery pressure waveform estimation device according to claim 10. Mansi does not explicitly disclose the model equation recited in the pending claims. The Examiner notes that the recited equation appears to be a general form of a logistic growth model. Selker also describes a device which derives a model of cardiac mechanics using logistic equations ([0006]), including the use of a logistic model similar to that claimed to determine the likelihood of a patient experiencing a cardiac abnormality ([0023]). Similarly, Feber also describes a device analyzes cardiac mechanics using logistic equations ([0138], equation 7). Based on the Selker and Feber references, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a logistic equation like the one recited in the pending claims in order to model the ventricular or pulmonary artery waveforms, as doing so would be a matter of using a known technique to improve a similar device or applying a known technique to a known device to yield predictable results (please see MPEP 2143).
Claims 8, 9, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mansi.
Regarding claims 8 and 17, Mansi describes a detection unit configured to detect one or more first biological signals related to the heartbeat and one or more second biological signals related to the arterial pressure ([0039], [0072]) and wherein the values of the one or more parameters is determined based on one or more of the one or more first biological signals and the one or more second biological signals ([0039]). Although Mansi does not explicitly disclose a “first” detection unit and a “second” detection unit, each configured to detect the heartbeat and arterial pressure signals, respectively, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use any number of detection units as necessary for efficient collection of the data, as doing so would be a matter of duplicating the known element of a detection unit or separating the function of Mansi’s single detection unit into multiple detection units, with both of these modifications having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04). The Examiner additionally notes that Mansi describes that any number of parameters, obtained from multiple physiological locations, may be obtained ([0039]) and multiple models may be derived, each being a component of a larger full-body model ([0043], [0092]), providing further motivation to incorporate two different detection units.
Regarding claims 9 and 18, Mansi, when modified to include a first and second detection unit as described above, describes wherein the first detection unit is configured to detect the one or more first biological signals by one or more first non-invasive methods or by one or more first minimally invasive methods, and the one or more second detection units are configured to detect the one or more second biological signals by one or more second non-invasive methods or by one or more second minimally invasive methods ([0025], [0077]).
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796